Early stage breast cancer is not an uncommon problem in the United States. It is estimated that there will be about 300,000 such cases in 2015. Since 1998, the Federal government has required that women are presented with all options for surgery and reconstruction of their affected breasts. This includes lumpectomy (i.e., removal of the cancerous mass and surrounding tissue) followed by radiation or mastectomy (i.e., removal of the entire breast) with or without reconstruction and possibly radiation therapy as well.
There are many options for treatment with lumpectomy or partial mastectomy followed by radiation treatment to the breast. In most cases in which radiation therapy is provided, a “boost” dose of radiation is delivered to the tumor bed in addition to a longer course of treatment for the entire breast or portion thereof. The boost can be performed in a variety of ways, such as delivery through a linear accelerator of photons or electron fields, radiation in the operating room, electromagnetic generation or radiation delivered by an after-loaded catheter/brachytherapy device.
With respect to the latter approach, the radiation is delivered, for example, via a group of flexible after-loading catheters that are placed in the breast (multi-catheter interstitial brachytherapy), a balloon that is connected to a catheter (balloon-based brachytherapy), modified forms of balloon-based therapy using a balloon catheter with multiple ports (e.g., one for insertion of the radiation source, a second for inflating the balloon with saline, and a third for drainage of seroma fluid or air), and other approaches. These devices will be collectively referenced as “boost-treatment devices.”
Normally, patients are fitted with the boost-treatment devices in the operating room or physician's office, radiation dosimetry is thereafter planned, and then the patient is sent home for several days before beginning electromagnetic or radioactive after-loading.
During this time period, women cannot comfortably wear a conventional brassiere or conventional surgical bra because of the presence of the multiple catheters extending under the axilla (arm pit) region. This leads to pain—back pain as a consequence of the lack of support for the breasts, pain as a consequence of the heaviness of the breasts without support after surgery, and pain at the wound site due to the presence of the catheters—and an inability to wear clothes in public without embarrassment. The most common complications for patients include infection, seroma and hematoma in the tumor bed cavity, as well as rotation/movement of the boost-treatment device.
The latter complication—rotation or other movement of the boost-treatment device—can be quite serious, leading to failure of consistent dose delivery. In this situation, the boost-treatment device needs to be removed before the radiation course is completed or necrosis occurs. Movement of the catheter necessitates additional radiation planning and often results in delays in the course of treatment. Not only does this cost money and take an emotional toll on the patient, but there is risk to the patient of further progression of disease.
Existing post-surgical bras cannot address the problems presented by boost treatment devices. U.S. Pat. No. 5,429,593 to Matory and U.S. Pat. No. 6,390,885 to Brooks, which are representative of the art, disclose surgery recovery brassieres with drainage tube apertures and tab closures. The tab closures, which are oriented horizontally, are intended to close the aperture (Matory) or to reduce the size of the aperture to better secure the drainage tubes therein (Brooks) to further reduce the movement of the tubes. The use of the tab closure, horizontal or otherwise, will not prevent rotation of any tubes extending through the aperture.